Pimecrolimus 1% Cream in the Treatment of Cutaneous Lesions of Pemphigus Vulgaris: A Double-blind, Placebo-controlled Clinical Trial

Background: Pemphigus vulgaris (PV) is a chronic, bullous disorder that is usually characterized by the presence of bulla and erosion on the skin and mucosa. Many studies on PV focus on the use of topical non-steroid agents. One of these agents is pimecrolimus; its efficacy is established in some inflammatory and autoimmune disorders such as oral and genital lichen planus. Patients, Materials and Methods: This was a double-blind study that was performed in 11 patients with confirmed diagnosis of PV. Patients under treatment with systemic steroid and azathioprine who had bilateral symmetrical oral lesions were selected and right- or left-sided lesions of those identified were randomized to be treated either by pimecrolimus 1% cream or placebo. The largest diameter of lesions was measured at the baseline and every 15 days for two times. Epithelization Index (EI) was calculated and data were analyzed with a program for statistical analysis. Results: Overall, 11 patients (62 cutaneous lesions; 31 lesions in the pimecrolimus group and 31 lesions in the placebo group) with cutaneous lesions of the pemphigus vulgaris were included in this study. At the end of day 15, there was significant difference regarding EI between the pimecrolimus and placebo groups. In addition, EI was significantly different at the end of study (day 30) in favor of pimecrolimus group (P=0.000). Conclusion: Pimecrolimus can be used as an effective and safe adjunctive treatment for cutaneous lesions of pemphigus vulgaris.